MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REV JOURNEY ART INS BCS STD 5-6 RT 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71934526
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery is needed for a patient due to infection.Poly exchange is required but no stock held in uk.This was noticed during a inspection in the tka procedure so the case is currently delayed since patient have not received the replacement.There is no more information provided for this event at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that a revision surgery is needed for a patient due to infection.Poly exchange is required.This was noticed during a inspection in the tka procedure so the case is currently delayed since patient have not received the replacement.There is no more information provided for this event at this time.
Additional Manufacturer Narrative
It was reported that a revision surgery is needed for a patient due to infection.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As lot information was not made available, device history record review cannot be completed.At this time, there is no information available to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode.A review of risk management files that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A medical analysis noted that no adequate materials was received to fully evaluate the complaint.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.B4 event description corrected.

• Brand Name: REV JOURNEY ART INS BCS STD 5-6 RT 11
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10681892
• Report Number: 1020279-2020-05411
• Device Sequence Number: 14193627
• Product Code: JWH
• UDI-Device Identifier: 00885556182161
• UDI-Public: 885556182161
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71934526
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention